Concept Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus drug coated balloon (DCB) catheter to treat peripheral artery disease (PAD) below-the-knee (BTK).
The company has developed the Sirolimus drug delivery platform technology called Nanolute technology, which was already used in coronary applications for more than 30,000 patients across the globe.
Development of MagicTouch PTA sirolimus coated balloon
Nanolute technology has been used for the development of MagicTouch PTA sirolimus coated balloon to use in the PAD application.
The technology will help convert sirolimus drug into sub-micron sized particles, as well as encapsulation of sub-micron sized Sirolimus drug into highly biocompatible drug carrier-phospholipid.
In April this year, the company also secured FDA breakthrough device designation for MagicTouch SCB to treat coronary artery disease (CAD) in patients with in-stent restenosis.
A Drug carrier with Sirolimus inside will be transferred to the vessel wall based on the principle of co-efficient diffusion, upon inflation of MagicTouch SCB at the target site.
Concept Medical is supported by cardiologist, philanthropist and serial entrepreneur Dr. Kiran Patel. Under the guidance of drug delivery pioneer Dr. Manish Doshi, the company has started evaluating various worldwide clinical programmes to create evidence for its innovative drug delivery devices.
Patel said: “The breakthrough designation demonstrates how important it is for us to have new technologies for BTK intervention. Patients with Critical Limb Ischemia (CLI) represent an enormous burden to our healthcare system and comprehensive care for these patients begins with effective revascularisation.”
